Tobacco alkaloid releasing chewing gum

ABSTRACT

The invention relates to a tobacco alkaloid releasing chewing gum comprising tobacco alkaloid, gum base, and chewing gum ingredients, said gum base comprising elastomer and resin-compounds constituting an amount in the range of about 2 to 20% by weight of said chewing gum.

BACKGROUND OF THE INVENTION

Pharmaceutical use of chewing gum is well known for different purposes.One of these purposes include the use of nicotine-releasing chewing gum,typically being applied for the purpose of providing a release ofnicotine in a users mouth over a certain period. A problem to be dealtwith in this context is that of emulating the nicotine release and oralperception of a cigarette when it is smoked by a user.

Different ways of incorporating the nicotine into the chewing gum bymixing or initial preparation of the nicotine has been disclosed in theprior art.

One of these prior art disclosures includes U.S. Pat. No. 5,488,962 Aspecifically dealing with the problem of simulating the cigarettesmoking with respect to the level of nicotine retention in the blood andsaliva. According to the disclosure, an initial peak of nicotine levelin the blood is obtained more similar to the corresponding, absorptionof nicotine when smoking a cigarette. The levels reached after a certaintime corresponds to conventional nicotine holding chewing gums.

A problem is, however, that the modification of the initial releasetypically results in a modified long-term release.

It is the object of the invention to obtain a tobacco alkaloid releasecorresponding to the release and absorption obtained when a user issmoking a cigarette.

SUMMARY OF THE INVENTION

The invention relates to a tobacco alkaloid releasing chewing gumcomprising tobacco alkaloid, gum base, and chewing gum ingredients, saidgum base comprising elastomer- and resin-compounds constituting anamount in the range of about 2 to 20% by weight of said chewing gum.

Generally, the term “tobacco alkaloid” herein refers to nicotine ornicotine substitutes.

According to the terms of the invention, the percentage of weight refersto the part(s) of the chewing gum comprising elastomer- and resincompounds, i.e. typically an uncoated chewing gum center, one or moregum base containing part(s) of a multimodular chewing gum, etc.

The term “resin compounds” includes both natural resins and syntheticresins as well as compounds referred to as “elastomer plasticizers”,i.e. polymer compounds implemented as plasticizers for elastomers.

Herein the term “gum base” refers both to a separately prepared gum basemixture and to the gum base components as such. In other words, thechewing-gum may be prepared in two steps by first mixing the gum baseand afterwards mixing gum base and chewing gum ingredients together, andthe chewing gum may alternatively be prepared in one step, e.g. byextruding and e.g. by a one step batch process such as disclosed in WO02/076229. In a one step process, the gum base components are added intothe chewing gum, although the gum base is not mixed separately.

A chewing gum may typically, according to an embodiment of theinvention, weigh in the range of 0.1 gram to 10 gram including anoptional coating, although other weights may apply.

In an embodiment of the invention, said chewing gum comprises tobaccoalkaloid in an amount of 0.1 mg to 10 mg.

In an embodiment of the invention, an advantageous concentration oftobacco alkaloid is within the range 0.1 mg to 10 mg per piece ofchewing gum, thereby obtaining a match between the applied amount oftobacco alkaloid in the chewing gum, the desired release of tobaccoalkaloid during chewing, the desired oral reception of tobacco alkaloidand acceptable textural properties.

In an embodiment of the invention, said chewing gum comprises tobaccoalkaloid in an amount of 0.1 mg to 10 mg in the gum base containingpart(s) of the chewing gum.

The gum base containing part of the chewing gum may typically be thechewing gum center, or core, basically forming an uncoated chewing gumpiece comprising essentially the whole chewing gum composition formedfrom chewing gum base and further ingredients. The chewing gum centermay be provided with an outer coating. In further embodiments of theinvention, the gum base containing part(s) are modules, e.g. layers, ofthe chewing gum and may even comprise the coating.

In an embodiment of the invention, said tobacco alkaloid is in a formselected from tobacco alkaloid salts, tobacco alkaloid bound in acomplex, or any combination thereof.

In an embodiment of the invention, said tobacco alkaloid is nicotine.

In an embodiment of the invention, said nicotine is in a form selectedfrom nicotine salts, nicotine free base, nicotine bound in a complex, orany combination thereof.

In an embodiment of the invention, said complex comprises an ionexchange resin.

In an embodiment of the invention, said ion exchange resin is a weaklyacidic cation exchange resin.

According to an embodiment of the invention, a preferred example of aweakly acidic cation exchange resin is polacrilex, which is described inUSP 24.

In an embodiment of the invention, said complex comprises an adsorbent.

In an embodiment of the invention, said adsorbent is selected from thegroup consisting of finely divided silicic acid, amorphous silica,magnesium silicate, calcium silicate, kaolin, clays, crystallinealuminosilicates, macaloid bentonite, activated carbon, alumina,hydroxylapatite, microcrystalline cellulose, or any combination thereof.

In an embodiment of the invention, said nicotine salts are selected fromthe group comprising nicotine hydrochloride, nicotine dihydrochloride,nicotine monotartrate, nicotine bitartrate, nicotine sulfate, nicotinezinc chloride, nicotine salicylate, or any combination thereof.

In an embodiment of the invention, said chewing gum comprisesemulsifiers in an amount in the range of 0.1% to 25% by weight of saidchewing gum.

As referred to herein, the term “emulsifier” covers the term“solubilizer”.

In an embodiment of the invention, at least 50% of said emulsifiers arecomprised in said gum base.

In an embodiment of the invention, said emulsifiers are selected fromthe group of cyclodextrins, polyoxyethylene castor oil derivatives,polyoxyethylene alkyl ethers, macrogol alkyl ethers, block copolymers ofethylene and propylene oxides, polyoxyethylene alkyl ethers,polyoxyethylene glycols, polyoxyethylene sorbitan fatty acid esters,polyoxyethylene (20) sorbitan monostearates, polyoxyethylene (20)sorbitan monooleates, polyoxyethylene stearates, sobitan esters,diacetyl tartaric ester of monoglycerides, lactylated monoglycerides, orany combination thereof.

In an embodiment of the invention, said chewing gum comprises one ormore emulsifiers having a HLB value of 7 or less.

According to the invention, emulsifiers of HLB (hydrophilic-lipophilicbalance) value below 7, or even below 5, may have advantageous softeningproperties, especially for softening of the gum base part of the chewinggum.

In an embodiment of the invention, said chewing gum comprises one ormore emulsifiers having a HLB value of at least 7.

According to the invention, emulsifiers of HLB above about 5, preferablyabove about 7, have advantageous properties for increasing the releaseof the tobacco alkaloid. According to the invention, these relativelyhigh-HLB-emulsifiers are preferably added at the same time in thechewing gum manufacturing process as the tobacco alkaloid.

In an embodiment of the invention, said chewing gum comprises one ormore emulsifiers having an HLB value of at least 10, preferably at least14.

In an embodiment of the invention, said chewing gum comprises one ormore emulsifiers of HLB value below about 7 and one or more emulsifiersof HLB value above about 7, said emulsifiers of HLB value below about 7being applied in the gum base, and said emulsifiers of HLB value aboveabout 7 being applied in the final chewing gum composition along withthe chewing gum ingredients.

In an embodiment of the invention, said resin-compounds comprise naturalresins constituting an amount in the range of 0.1 to 20% by weight ofsaid chewing gum.

In an embodiment of the invention, said resin-compounds comprise naturalresins constituting an amount in the range of 1 to 15% by weight of saidchewing gum.

In an embodiment of the invention, said natural resins comprise estergums.

In an embodiment of the invention, said resin-compounds comprisesynthetic resins constituting an amount in the range of 0.1 to 20% byweight of said chewing gum.

In an embodiment of the invention, said resin-compounds comprisesynthetic resins constituting an amount in the range of 1 to 15% byweight of said chewing gum.

In an embodiment of the invention, said synthetic resins compriseterpene resins derived from alpha-pinene, beta-pinene and/or d-limonene.

In an embodiment of the invention, said synthetic resins comprisepolyvinyl acetate (PVAc).

In an embodiment of the invention, said elastomer compounds comprises atleast 1% by weight of said chewing gum, preferably at least 2% by weightof said chewing gum.

According to an embodiment of the invention, an advantageous amount ofelastomer should be at least 1% by weight of the chewing gum, therebyobtaining a match between the applied amount of tobacco alkaloid in thechewing gum, the desired release of tobacco alkaloid during chewing, thedesired oral reception of tobacco alkaloid and acceptable texturalproperties.

In an embodiment of the invention, said elastomer compounds constituteless than 20% by weight of said chewing gum, preferably less than about15% by weight of said chewing gum and most preferably less than 10% byweight of said chewing gum.

According to an embodiment of the invention, the amount of elastomersshould be carefully controlled in order to obtain the desired gumproperties especially with respect to the initial chew of the chewinggum, as an initial high chew-resistance may counteract the resultingrelease of tobacco alkaloid.

In an embodiment of the invention, said elastomer compounds constitutean amount in the range of about 0.001 to 20% by weight of said chewinggum, preferably within the range of about 0.001 to 15% by weight of saidchewing gum and most preferably within the range of about 0.001 to 10%by weight of said chewing gum.

In an embodiment of the invention, the amount of elastomers should becarefully controlled in order to obtain the desired gum properties, bothwith respect to the right chew feel and with respect to avoiding a highmount of elastomers, thereby counteracting especially the initialchewing and thereby the initial chew-invoked release of especiallytobacco alkaloid.

In an embodiment of the invention, said elastomer compounds aresynthetic elastomers selected from the group comprisingbutadiene-styrene copolymers, polyisobutadiene, isobutylene-isoprenecopolymers, butyl rubber, polybutene, polybutadiene, polyisobutylene,polyvinyl acetate, polyethylene, vinyl acetate/vinyl laurate copolymer,vinyl acetate/vinyl stearate copolymer, ethylene/vinyl acetatecopolymer, polyvinyl alcohol, or any derivatives or mixtures thereof.

In an embodiment of the invention, said elastomer compounds are naturalelastomers selected from the group comprising natural rubber, latex,guayule, natural gums, jelutong, lechi caspi, perillo, sorva,massaranduba balata, massaranduba chocolate, nispero, rosidinha, chicle,gutta percha, gutta kataiu, niger gutta, tunu, chilte, chiquibul, guttahang kang, or any combination thereof.

In an embodiment of the invention, said chewing gum comprises pHcontrolling components.

In an embodiment of the invention, said pH controlling components areselected from the group of sodium carbonate, sodium hydrogen carbonate,potassium carbonate, potassium hydrogen carbonate, dipotassiumphosphate, potassium citrate, or any combination thereof.

In an embodiment of the invention, said pH controlling componentscomprise an amount in the range of 0.1% to 5% by weight of said chewinggum.

In an embodiment of the invention, said pH controlling components areimplying a pH value in the range of 7.4 to 10 in the buccal cavity of auser of said chewing gum.

As a fast release of nicotine from the chewing gum is provided accordingto the invention, a problem arises that the user may swallow a largepart of the released nicotine. The nicotine part, which is swallowed, iswasted, as it is not absorbed into the bloodstream of the user. A way ofreducing this problem, according to the invention, is to raise thepH-value in the mouth to a value at which absorption of nicotine isfacilitated. Thus, a raised pH-value in the mouth of the user is a veryimportant factor, according to the invention, in order to achieve thebenefits of having obtained a fast release.

In an embodiment of the invention, said fast tobacco alkaloid releasingchewing gum comprises a coating.

According to the invention, it has been experienced that the fastreleasing chewing gum may offer a reduced protection of tobacco alkaloidleading to a reduced stability of tobacco alkaloid within the chewinggum. The reduced stability may be observed both with regard to escapetobacco alkaloid, e.g. nicotine from the chewing gum due to itsvolatility and access of oxygen to the tobacco alkaloid incorporated inthe chewing gum composition. It has, however, been found, according tothe invention, that a coating of the chewing gum may provide an improvedprotection and increased stability of the tobacco alkaloid in thechewing gum.

The improved protection is mainly implying that escape of volatiletobacco alkaloid is reduced and that access light and of oxygen from theair is reduced. By reducing the oxygen access, reactions between oxygenand nicotine are reduced, thereby maintaining tobacco alkaloid in thepreferred form. Likewise, reduction of light access to the tobaccoalkaloid reduces the occurrence of oxidation and further reactions ofthe tobacco alkaloid such as nicotine. Thus, a significant advantageobtained by applying a coating according to the invention is that a moresimple and less expensive wrapping or packaging may be applied comparedto the packaging, which is typically necessary for protection of chewinggum comprising a tobacco alkaloid.

In an embodiment of the invention, said coating is a hard coating.

According to the invention, especially a hard coating is providing thechewing gum with improved protective characteristics as regardsprotection of tobacco alkaloid within the chewing gum.

In an embodiment of the invention, said coating is a soft coating or afilm coating.

Also, a soft coating and a film coating may, according to the invention,provide some contribution to the protection of tobacco alkaloid contentsin the chewing gum.

In an embodiment of the invention, said coating comprises a furtheramount of tobacco alkaloid.

When incorporating tobacco alkaloid in the coating an initial very fastrelease of tobacco alkaloid may be obtained. Again, this advantage maybe utilized together with the benefits of the applied amounts ofresinous and elastomers, which may basically take over from the coatingwhen the initial burst of tobacco alkaloid has been obtained andmaintain a continuous release of tobacco alkaloid even after the coat isdissolved.

In an embodiment of the invention, said coating has a weight above 20mg, preferably above 50 mg, and most preferably above 100 mg.

In experiments performed by the inventor coatings with a weight ofapproximately 20 mg has been successfully applied to the chewing gumcenter. In chewing gum with coatings of approximately 100 mg, aprotective effect has been observed in keeping volatile nicotine insidethe chewing gum.

The weight of the uncoated chewing gum center may be within the range of0.4 g to 10 g.

In an embodiment of the invention, said coating make up more than 2%,preferably more than 5%, and most preferably more than 10% by weight ofthe chewing gum.

In an embodiment of the invention, said chewing gum comprises a coatingcomprising a portion of at least 100 milligrams and wherein said portioncomprises high-intensity sweetener.

In an embodiment of the invention, said coating comprising a portion ofat least 100 milligrams and wherein said portion comprises bulksweetener.

In an embodiment of the invention, said coating comprising at least aportion of at least 100 milligrams and wherein said portion comprisesflavor.

In an embodiment of the invention, said chewing gum comprisessweeteners.

In an embodiment of the invention, said sweeteners comprise bulksweeteners, sugar sweeteners, sugar substitute sweeteners, artificialsweeteners, high-intensity sweeteners, or any combination thereof.

In an embodiment of the invention, said chewing gum comprises one ormore flavoring agents.

In an embodiment of the invention, said flavoring agents comprisenatural and synthetic flavorings.

In an embodiment of the invention, said flavoring agents compriseessential oils, essences, extracts, powders, acids, coconut, coffee,chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice,caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds,pineapple, strawberry, raspberry, apple, pear, peach, apricot,blackberry, cherry, pineapple, plum essence, clove oil, bay oil, anise,thyme, cedar leaf oil, nutmeg, cinnamon, peppermint, wintergreen,spearmint, eucalyptus, mint, or any combination thereof.

In an embodiment of the invention, said chewing gum comprises filler.

In an embodiment of the invention, said filler is comprised within saidgum base.

In an embodiment of the invention, said filler is incorporated in saidchewing gum along with said chewing gum ingredients.

In an embodiment of the invention, said chewing gum has a weight in therange of 0.1 to 10 grams.

In an embodiment of the invention, said chewing gum is multimodular.

In an embodiment of the invention, said chewing gum comprises a fasttobacco alkaloid releasing module, preferably a substantially gum basefree module.

In an embodiment of the invention, said chewing gum is a chewing gumtablet.

Apart from being mixing in one step or two steps or extruded, thechewing gum according to the invention may also be prepared bytabletting, i.e. by compression of the chewing gum components. A chewinggum piece prepared by tabletting may be referred to as a chewing gumtablet.

In an embodiment of the invention, said chewing gum comprises furtheractive ingredients.

Examples of further active ingredients applicable within the scope ofthe invention are listed in the detailed description.

According to the invention, the further active ingredients areincorporated in the chewing gum center or core of the chewing gum.Hereby, a synchronized release of tobacco alkaloid and further activeingredients may be obtained according to the invention. Thus, effects ofthe tobacco alkaloid may be increased or compensated in a synchronizedmanner.

In an embodiment of the invention, the amount of said further activeingredients is within the range of about 0.01 mg to 1000 mg, preferablyin the range of 0.01 mg to 500 mg.

In an embodiment of the invention, said further active ingredients areselected from the group consisting of dental agents and agents fortreating pain, headache, or weight-gain. Such active ingredients arelisted in the detailed description.

In an embodiment of the invention, said further active ingredients areselected from the group consisting of cetirizine, loratidin,phenyleferin, paracetamol, cimetidin, ranitidin, ibuprofen,calciumcarbonat, vitamin D3, sumatriptan, ketoprofen, naproxen,morphine, cimetidine, famotidine, ranitidine, chlorpheneramine,dextrometorphane, metformine, or any combination thereof.

In an embodiment of the invention, said emulsifiers are selected fromthe group of cyclodextrins, polyoxyethylene (20) sorbitan monostearates,sorbitan fatty acid esters, glycerol polyethyleneglycol oxystearate,glycerol monostearate, glycerol monooleate, block copolymers of ethyleneand propylene oxides, or mixtures thereof.

Moreover, the invention relates to a method of preparing a fast tobaccoalkaloid releasing chewing gum according to any of the claims 1 to 60.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in the following with reference to thedrawing, where

FIG. 1 illustrates release percentage as a function of time for nicotinecontaining chewing gums having different gum base contents.

DETAILED DESCRIPTION OF THE INVENTION

According to the present invention, a fast tobacco alkaloid releasingchewing gum has been provided. The chewing gum has shown remarkableincreased release of tobacco alkaloid such as nicotine during the firstminutes of chewing.

In general, a chewing gum composition typically comprises awater-soluble bulk portion, a water-insoluble chewable gum base portionand flavoring agents. The water-soluble portion dissipates with aportion of the flavoring agent over a period of time during chewing. Thegum base portion is retained in the mouth throughout the chew. The term“chewing gum” refers to both a chewing and bubble type gum in itsgeneral sense.

The gum base is the masticatory substance of the chewing gum, whichimparts the chew characteristics to the final product. The gum basetypically defines the release profile of flavors and sweeteners andplays a significant role in the gum product.

The insoluble portion of the gum typically may contain any combinationof elastomers, vinyl polymers, elastomer plasticizers, waxes, softeners,fillers and other optional ingredients such as colorants andantioxidants.

The composition of gum base formulations can vary substantiallydepending on the particular product to be prepared and on the desiredmasticatory and other sensory characteristics of the final product.However, typical ranges (% by weight of the gum base) of the above gumbase components are: 1 to 50% elastomeric compounds, 5 to 55% elastomerplasticizers, 0 to 40% waxes, 5 to 35% softeners, 0 to 50% fillers, and0 to 5% miscellaneous ingredients such as antioxidants, colorants, etc.

Elastomers provide the rubbery, cohesive nature to the gum, which variesdepending on this ingredient's chemical structure and how it may becompounded with other ingredients. Elastomers suitable for use in thegum base and gum of the present invention may include natural orsynthetic types.

The elastomer may be any water-insoluble polymer known in the art, andincludes those gum polymers utilized for chewing gum and bubble gumlisted in Food and Drug Administration, CFR, Title 21, Section 172,615,as “Masticatory Substances of Natural Vegetable Origin” and “MasticatorySubstances, Synthetic”

Useful natural elastomers include natural rubber such as smoked orliquid latex and guayule, natural gums such as jelutong, lechi caspi,perillo, sorva, massaranduba balata, massaranduba chocolate, nispero,rosidinha, chicle, gutta percha, gutta kataiu, niger gutta, tunu,chilte, chiquibul, gutta hang kang.

Useful synthetic elastomers include high-molecular weight elastomerssuch as butadiene-styrene copolymers, polyisobutadiene andisobutylene-isoprene copolymers, low-molecular weight elastomers such aspolybutene, polybutadiene and polyisobutylene, vinyl polymericelastomers such as polyvinyl acetate, polyethylene, vinyl copolymericelastomers such as vinyl acetate/vinyl laurate, vinyl acetate/vinylstearate, ethylene/vinyl acetate, polyvinyl alcohol or mixtures thereof.

Butadiene-styrene type elastomers, or SBR as they may be called,typically are copolymers of from about 20:80 to 60:40 styrenes:butadienemonomers. The ratio of these monomers affects the elasticity of the SBRas evaluated by mooney viscosity. As the styrene:butadiene ratiodecreases, the mooney viscosity decreases. The structure of SBRtypically consists of straight chain 1,3-butadiene copolymerized withphenylethylene (styrene) and provides the non-linear molecular nature ofthese elastomers. The average molecular weight of SBR is <600.000g/mole.

Isobutylene-isoprene type elastomers, or butyl as they may be called,have molar percent levels of isoprene ranging from 0.2 to 4.0. Similarto SBR, as the isoprene:isobutylene ratio decreases, so does theelasticity, measured by mooney viscosity.

The structure of butyl rubber typically consists of branched2-methyl-1,3-butadiene (isoprene) copolymerized with branched2-methylpropene (isobutylene), and, as with SBR, this type of structureis non-linear in nature. The average molecular weight of SBR is in therange from 150,000 g/mole to 1,000,000 g/mole.

Polyisobutylene, or PIB as they may be called, type elastomers arepolymers of 2-methylpropene and, as with SBR and butyl, are non-linearin nature. The low-molecular weight elastomers provide soft chewcharacteristics to the gum base and still provide the elastic qualitiesas do the other elastomers. Average molecular weights may range fromabout 30,000 to 120,000 g/mole and the penetration may range from about4 millimeters to 20 millimeters. The higher the penetration, the softerthe PIB. Similar to the SBR and butyl, the high-molecular weightelastomers provide elasticity to the gum. Average molecular weight mayrange from 120,000 to 1,000,000 g/mole.

Polybutenes range in average molecular weight from about 5.000 g/mole toabout 30.000 g/mole.

Vinyl polymeric and copolymeric type elastomers provide tack resistance,vary the chew characteristics of gums made from these bases having vinylpolymers and offer hydrophilic properties beneficial to sensoryperception of the final gums.

For vinyl copolymeric types, the amount of vinyl laurate, vinylstearate, or ethylene present in the vinyl laurate/vinyl acetate(VL/VA), vinyl stearate/vinyl acetate (VS/VA), or ethylene/vinyl acetate(EVA) copolymers respectively typically ranges from about 10 to about60% by weight of the copolymer. Average molecular weights of thesepolymers may range from about 2.000 g/mole to about 100.000 g/mole.

The vinyl polymers such as polyvinyl alcohol and polyvinyl acetate havean average molecular weight from about 8.000 g/mole to about 65.000g/mole.

Polymers of vinyl acetate (PVAc) are branched in nature. The degree ofbranching is increased when vinyl acetate monomers are copolymerizedwith vinyl laurate, vinyl stearate, ethylene and the like. The higherthe degree of branching, the higher the compatibility when blended orcompounded with normal-alkanic and iso-alkanic type waxes.

It is e.g. common in the industry to combine in a gum base a syntheticelastomer having a high-molecular weight and a low-molecular-weightelastomer. Presently preferred combinations of synthetic elastomersinclude, but are not limited to, polyisobutylene and styrene-butadiene,polyisobutylene and polyisoprene, polyisobutylene andisobutylene-isoprene copolymer (butyl rubber) and a combination ofpolyisobutylene, styrene-butadiene copolymer and isobutylene isoprenecopolymer, and all of the above individual synthetic polymers inadmixture with polyvinyl acetate, vinyl acetate-vinyl lauratecopolymers, respectively and mixtures thereof.

Elastomer plasticizers vary the firmness of the gum base. Theirspecificity on elastomer inter-molecular chain breaking (plasticizing)along with their varying softening points cause varying degrees offinished gum firmness and compatibility when used in base. This may beimportant when one wants to provide more elastomeric chain exposure tothe alkanic chains of the waxes.

Elastomer plasticizers suitable for use in the present invention includenatural rosin esters often referred to as ester gums. Such elastomerplasticizers known in the art are methyl, glycerol and pentaerythritolesters of rosins and modified rosins, such as hydrogenated, dimerizedand polymerized rosins. Examples are glycerol ester of wood and gumrosin, glycerol ester of partially hydrogenated wood and gum rosin,glycerol ester of polymerized wood and gum rosin, glycerol ester ofpartially dimerized wood and gum rosin, glycerol ester of tall oilrosin, pentaerythritol ester of wood and gum rosin, pentaerythritolesters of partially and fully hydrogenated wood and gum rosin, methylesters of wood and gum rosins and partially and fully hydrogenatedmethyl esters of wood and gum rosin.

The synthetic elastomer plasticizers include terpene resins derived fromalpha-pinene, beta-pinene and/or d-limonene.

The elastomer plasticizers used may be of one type or of combinations ofmore than one type. Typically, the ratios of one to the other aredependent on each respective softening point, the effect on flavorrelease, and the respective degree of tack they cause to the gum. Balland ring softening points of the rosin ester types described above mayrange from about 45° C. to about 120° C. Softening points of the terpeneresins may range from about 60° C. to about 130° C.

Petroleum waxes aid in the curing of the finished gum made from the gumbase as well as improve shelf life and texture. Wax crystal sizeinfluences the release of flavor. Those waxes high in iso-alkanes have asmaller crystal size than those waxes high in normal-alkanes, especiallythose with normal-alkanes of carbon numbers less than 30. The smallercrystal size allows slower release of flavor since there is morehindrance of the flavor's escape from this wax versus a wax havinglarger crystal sizes. The compatibility of gum bases made usingnormal-alkanic waxes is less when compared to gum bases made withiso-alkanic waxes.

Petroleum wax (refined paraffin and microcrystalline wax) and paraffinwax are composed of mainly straight-chained normal-alkanes and branchediso-alkanes. The ratio of normal-alkanes to iso-alkanes varies.

The normal-alkanic waxes typically have carbon chain lengths >C-18 butthe lengths are not predominantly longer than C-30. The branched andring structures are located near the end of the chain for those waxesthat are predominantly normal-alkanic. The viscosity of normal-alkanicwaxes is <10 mm2/s (at 100° C.) and the combined number averagemolecular weight is <600 g/mole.

The iso-alkanic waxes typically have carbon lengths that arepredominantly greater than C-30. The branched chains and ring structuresare located randomly along the carbon chain in those waxes that arepredominantly iso-alkanic. The viscosity of iso-alkanic waxes is greaterthan 10 mm2/s (at 100° C.) and the combined number average molecularweight is >600 g/mole.

Synthetic waxes are produced by means that are atypical for petroleumwax production and are thus not considered petroleum wax. The syntheticwaxes may include waxes containing branched alkanes and copolymerizedwith monomers such as, but not limited to propylene, polyethylene, andFischer Tropsch type waxes. Polyethylene wax is a synthetic waxcontaining alkane units of varying lengths having attached theretoethylene monomers.

The natural waxes may include rice bran wax, bees' wax, carnauba wax orcandelilla wax. The waxes may be used alone or in any combination.

The selection of softeners has an influence on the softness of the base.Softeners modify the texture, cause the hydrophobic and hydrophiliccomponents of the base to be miscible, and may further plasticize thesynthetic elastomers of the gum base. The emulsifiers, which belong tothe group of softeners, provide the gum base with water-bindingproperties, which confer to the gum base a pleasant smooth surface andreduce its adhesive properties.

Softeners suitable for use in the gum base include triglycerides ofnon-hydrogenated, partially hydrogenated and fully hydrogenatedvegetable oils and tallow, cocoa butter and degreased cocoa powder andin addition to these the emulsifiers.

The group of triglycerides include cottonseed, palm, palm kernel,coconut, safflower, rapeseed, sunflower, tallow, soybean, cocoa butter,medium-chained triglycerides and the like.

The caproic, caprylic, capric, myristic, lauric and palmitic fatty acidsof the triglycerides tend to plasticize the synthetic elastomers morethan triglycerides containing predominantly stearic fatty acid.

To the group of emulsifiers belong the monoglycerides, diglycerides,acetylated mono and diglycerides, distilled mono- and diglycerides,glycerol monostearate, propylene glycol monostearate, Na-, K-, Mg- andCa-stearates, glycerol triacetate, fatty acid monoglycerides (e.g.stearic, palmitic, oleic and linoleic acids), lactic acid esters andacetic acid esters of mono- and diglycerides, sugar esters of ediblefatty acids also referred to as sucrose polyesters including thosedisclosed in WO 00/25598, lecithin and hydroxylated lecithin, most ofthese may contain triglyceride levels less than 2% by weight from theirmanufacturing processing.

The softeners including the emulsifiers may be used alone or at leasttwo or more in combination.

Fillers used in gum base modify the texture of the gum base and aid inprocessing. Particle size has an effect on cohesiveness, density andprocessing characteristics of the gum base and its compounding. Thesmaller the particle size, the more dense and cohesive the final gumbase. Also, by selecting fillers based on their particle sizedistribution, initial mass compounding may be varied, thus allowingalteration of the compounding characteristics of the initial mass duringgum base processing and ultimately the final chew characteristics ofgums made from these gum bases.

Fillers suitable for use in the gum base include magnesium and calciumcarbonate, ground limestone and silicate types such as magnesium andaluminum silicate, kaolin and clay, aluminum oxide, silicium oxide,talc, as well as titanium oxide, mono-, di- and tricalcium phosphate,sodium sulphate, cellulose polymers such as ethyl, methyl and wood ormixtures thereof.

Talc filler may be used in the gum base and gum of the present inventionthat may come in contact with or employ acid flavors or provide anacidic environment needed to prevent degradation of an artificialsweetener by reacting with calcium carbonate type fillers. Mean particlesize for calcium carbonate and talc fillers typically range from about0.1 micron to about 15 microns.

The fillers may also include natural organic fibers such as fruitvegetable fibers, grain, rice, cellulose and combinations thereof.

Antioxidants prolong shelf life and storage of gum base, finished gum ortheir respective components including fats and flavor oils.

Antioxidants suitable for use in gum base include butylatedhydroxyanisole (BHA), butylated hydroxytoluene (BHT), betacarotenes,tocopherols, acidulants such as Vitamin C, propyl gallate, othersynthetic and natural types or mixtures thereof.

Flavorants and colorants impart characteristics or remove or maskundesired characteristics. Colorants may typically include FD&C typelakes, plant extracts, fruit and vegetable extracts and titanium dioxideflavorants may typically include cocoa powder, heat-modified amino acidsand other vegetable extracts.

Gum bases are typically prepared by adding an amount of the elastomer,elastomer plasticizer and filler, and on occasion a vinyl polymer, to aheated (10° C.-120° C.) sigma blade mixer with a front to rear speedratio of from about 1.2:1 to about 2:1, the higher ratio typically beingused for gum base which requires more rigorous compounding of itselastomers.

The initial amounts of ingredients comprising the initial mass may bedetermined by the working capacity of the mixing kettle in order toattain a proper consistency and by the degree of compounding desired tobreak down the elastomer and increase chain branching. The higher thelevel of filler at the start or selection of a filler having a certainparticle size distribution, the higher the degree of compounding andthus more of the elastomeric chain crosslinking are broken, causing morebranching of the elastomer thus lower viscosity gum bases and thussofter final gum base and gum made from such a gum base. The longer thetime of compounding, the use of lower molecular weight or softeningpoint gum base ingredients, the lower the viscosity and firmness of thefinal gum base.

Compounding typically begins to be effective once the ingredients havemassed together. Anywhere from 15 minutes to 90 minutes may be thelength of compounding time.

Preferably, the time of compounding is from 20 minutes to about 60minutes. The amount of added elastomer plasticizer depends on the levelof elastomer and filler present. If too much elastomer plasticizer isadded, the initial mass becomes over plasticized and not homogeneous.

After the initial ingredients have massed homogeneously and compoundedfor the time desired, the balance of the gum base ingredients are addedin a sequential manner until a completely homogeneous molten mass isattained. Typically, any remainder of elastomer, elastomer plasticizer,vinyl polymer and filler, are added within 60 minutes after the initialcompounding time. The filler and the elastomer plasticizer wouldtypically be individually weighed and added in portions during thistime. The optional waxes and the softeners are typically added after theelastomer and elastomer plasticizers and during the next 60 minutes.Then the mass is allowed to become homogeneous before dumping.

Typical gum base processing times may vary from about one to about threehours, preferably from about 1½ to 1½ hours, depending on theformulation. The final mass temperature when dumped may be between 70°C. and 130° C. and preferably between 100° C. and 120° C. The completedmolten mass is emptied from the mixing kettle into coated or lined pans,extruded or cast into any desirable shape and allowed to cool andsolidify. Those skilled in the art will recognize that many variationsof the above-described procedure may be followed.

The water-soluble portion of the chewing gum may comprise chewing gumingredients such as softeners, sweeteners, high-intensity sweeteners,flavoring agents, acidulants, fillers, antioxidants, and othercomponents that provide desired attributes. Softeners typicallyconstitute from about 0.5% to about 25.0% by weight of the chewing gum.The bulking agents generally comprise from about 5% to about 90%,preferably from about 20% to about 80% of the chewing gum.High-intensity sweeteners in gum typically may range from about 0.01 to0.50 weight percent. A flavoring agent may be present in the chewing gumin an amount within the range of from about 0.1 to about 30.0 weightpercent of the gum.

According to the present invention, the term “tobacco alkaloid” includesboth nicotine and nicotine-like alkaloids and may be in free base formor any pharmacologically acceptable acid addition salt form.

According to the invention, nicotine or other tobacco alkaloids may beapplied in a chewing gum from which they are rapidly released duringchewing. The term “nicotine” includes diprotonated nicotine,monoprotonated nicotine as well as nicotin free base. Further tobaccoalkaloids, which may substitute nicotine, include such compounds ascotinine, norcotile, nornicotine, lobeline, derivatives of lobeline,nicotine N-oxide, cotinine N-oxide, 3-hydroxycotile, 5-hydroxycotile,derivatives of epibatidine, N-methylcarbamyl, N-methylthi-O-carbamylesters of choline, acetylcholine, and etc.

Preferred nicotine substitutes according to the invention include plantalkaoids obtainable from species of Nicotiana, which is a source fornicotine and nor-nicotine, as well as species of Lobelia and Lobeliaceae(Indian tobacco), which are a source for lobeline.

The tobacco alkaloid, i.e. nicotine or the substitutes therefore maypreferably be added into the chewing gum at the stage of mixing thechewing gum ingredients with the gum base. It is, however, within thescope of the invention to mix nicotine into the gum base. The nicotineis preferably substantially uniformly distributed in the chewing gum orin a part of the chewing gum.

The amount of nicotine or other tobacco alkaloids added into the chewinggum may, according to the invention, be within the range of 0.1 mg to 10mg, preferably 0.5 mg to 5 mg, and most preferably 1 mg to 4 mg. Typicaldoses of 2 mg and 4 mg nicotine in a nicotine chewing gum may also beapplied in embodiments of the present invention.

According to a preferred embodiment of the invention, nicotine may beapplied as the tobacco alkaloid. Nicotine may be added in a free baseform, but preferably nicotine is bound as a salt and/or in a complexprior to addition into the chewing gum mixture. Both absorption andadsorption may be suitable ways of binding nicotine to a suitablecomplex or compound.

In a nicotine-containing complex, nicotine may be bound to a cationexchange resin. The cation exchanging groups may be strongly acidic,intermediately acidic, or weakly acidic, depending on the acid fromwhich the functional groups are derived. Examples of suitable acidicgroups include carboxylic, sulphonic, phosphonous, phosphoric,iminodiacetic, and phenolic acid. If the ion exchange resin furthercomprises anionic groups, a polyampholyte may be obtained, and by usinga suitable mixture of counter-ions, the release characteristics may bevaried.

The ion exchange resins according to the invention comprise acidic ions,which are bound to a polymer such as a crosslinked or a linear polymer.Examples include addition polymers of styrene and divinylbenzene,divinylbenzene and methacrylic acid or acrylic acid, phenolic resins,cellulose, and etc.

Further details about applicable ion exchange resins are outlined inU.S. Pat. No. 3,845,217 and U.S. Pat. No. 3,901,248, hereby incorporatedby reference.

A preferred complex for binding nicotine before addition into thechewing gum is a weakly acidic cation exchange resin such as polacrilexaccording to USP 24 United States Pharmacopeia no. 24), which isavailable as Amberlite IRP 64.

Further suitable alternative complexes, which may be applied accordingto the present invention are adsorbent complexes, wherein nicotine oranother alkaloid is bound to or sorbed on an adsorbent such as finelydivided silicic acid, amorphous silica, magnesium silicate, calciumsilicate, kaolin, clays, crystalline aluminosilicates, macaloidbentonite, activated carbon, alumina, hydroxylapatite, microcrystallinecellulose, and the like. Further details about adsorbents for nicotineare outlined in U.S. Pat. No. 3,877,468 and WO2004/056363, herebyincorporated by reference.

According to a further embodiment of the invention, different tobaccoalkaloids are applied in the chewing gum at the same time, and may evenbe bound in the same complex, such as in the above-mentioned adsorbentsor ion exchange resins.

According to an embodiment of the invention, nicotine is a preferredtobacco alkaloid for application in the fast releasing chewing gum ofthe invention. Thus, it should generally be noted that nicotine is apreferred tobacco alkaloid. However, it should further be noted thatspecific examples and explanations specifically referring to nicotine asactive agent against craving in no way restrict the scope of theinvention with respect to use of other tobacco alkaloids for the samespecific purpose. A specific mentioning of nicotine at any place in thisapplication is only used for the purpose of exemplifying the inventionin a tangible way and not for the purpose of excluding alternativefunctional equivalents.

Furthermore, according to the present invention, the term “nicotine” mayencompass nicotine or nicotine derivatives in any form such as, e.g.physical forms like amorphous, crystalline, polymorphous, etc. orchemical forms like isomers and enantiomers, etc. as well as anypharmaceutically acceptable salts, complex or solvate thereof. Nicotinemay be selected from nicotine base, nicotine hydrochloride, nicotinedihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotinesulfate, nicotine zinc chloride such as zinc chloride monohydrate andnicotine salicylate.

Softeners are added to the chewing gum in order to optimize thechewability and mouth feel of the gum.

Softeners contemplated for use in the gum include glycerin, modifiedlecithin and combinations thereof. Further aqueous sweetener solutionssuch as those containing sorbitol, hydrogenated starch hydrolysates,corn syrup and combinations thereof may be used as softeners.

Bulk sweeteners include both sugar and sugarless components. Bulksweeteners may typically constitute 5 to about 95% by weight of thechewing gum, more typically constitute 20 to about 80% by weight, andmore commonly, 30 to 60% by weight of the gum.

The sweeteners often fill the role of bulking agents in the gum. Thesweeteners are improving juiciness of the gum and are supporting theflavor profile of the gum. Sugar sweeteners generally include, but arenot limited to saccharide-containing components commonly known in thechewing gum art, such as sucrose, dextrose, maltose, saccharose,lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar,fructose, levulose, galactose, corn syrup solids, glucose syrup,hydrogenated glucose syrup, and the like, alone or in combination.

The sweetener can be used in combination with sugarless sweeteners.Generally, sugarless sweeteners include components with sweeteningcharacteristics but which are devoid of the commonly known sugars andcomprise, but are not limited to, sugar alcohols such as sorbitol,mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt,erydiritol, lactitol and the like, alone or in combination.

Depending on the particular sweetness release profile and shelf lifestability needed, bulk sweeteners can also be used in combinationhigh-intensity sweeteners. Preferred high-intensity sweeteners include,but are not limited to sucralose, aspartame, salts of acesulfame,alitame, saccharin and its salts, cyclamic acid and its salts,cyclamate, glycyrrhizin, dihydrochalcones, thaumatin, monellin,sterioside and the like, alone or in combination. In order to providelonger lasting sweetness and flavor perception, it may be desirable toencapsulate or otherwise control the release of at least a portion ofthe artificial sweetener. Such techniques as wet granulation, waxgranulation, spray drying, spray chilling, fluid bed coating,coascervation, encapsulation in yeast cells and fiber extrusion may beused to achieve the desired release characteristics. The encapsulationcan also be performed in another material such as resin.

Usage level of the artificial sweetener will vary greatly and willdepend on such factors as potency of the sweetener, rate of release,desired sweetness of the product, level and type of flavor used and costconsiderations. Thus, the active level of artificial sweetener may varyfrom 0.02 to about 8%. When carriers used for encapsulation areincluded, the usage level of the encapsulated sweetener will beproportionally higher. Combinations of sugar and/or sugarless sweetenersmay be used in chewing gum.

Additionally, the softener may also provide additional sweetness, ifsuch softeners as aqueous sugar or alditol are used.

If a low-calorie gum is desired, a low-caloric bulking agent can beused. Examples of low-caloric bulking agents include polydextrose;Raftilose, Raflilin; Fructooligosaccharides (NutraFlora@); Palatinoseoligosaccharide; Guar Gum Hydrolysate (SunFiber@); or indigestibledextrin (Fibersol). However, other low-caloric bulking agents can beused.

The chewing gum centers provided herein may contain aroma agents andflavoring agents including natural and synthetic flavorings e.g. in theform of natural vegetable components, essential oils, essences,extracts, powders, including acids and other substances capable ofaffecting the taste profile. Examples of liquid and powdered flavoringsinclude coconut, coffee, chocolate, vanilla, grape fruit, orange, lime,menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew,hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits,cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, andmint, fruit essence such as from apple, pear, peach, strawberry,apricot, raspberry, cherry, pineapple, and plum essence. The essentialoils include peppermint, spearmint, menthol, eucalyptus, clove oil, bayoil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits (e.g.lemon, bergamot and orange) as mentioned above.

The chewing gum flavor may be a natural flavoring agent, which isfreeze-dried, preferably in the form of a powder, slices or pieces ofcombinations thereof. The particle size may be less than 3 mm,preferably less than 2 mm, more preferably less than 1 mm, calculated asthe longest dimension of the particle. The natural flavoring agent maybe in a form where the particle size is from about 3 μm to 2 mm, such asfrom 4 μm to 1 mm. Preferred natural flavoring agents include seeds froma fruit e.g. from strawberry, blackberry and raspberry.

Various synthetic flavors, such as mixed fruit flavors may also be usedin the present chewing gum centers. The aroma agent may be used inquantities smaller than those conventionally used. The aroma agentsand/or flavors may be used in an amount of from 0.01 to about 30% byweight (preferably from 0.01 to about 15% by weight) of the finalproduct depending on the desired intensity of the aroma and/or flavorused. Preferably, the content of aroma/flavor is in the range of from0.2 to 3% by weight of the total composition.

Also various acids are used typically in combination with fruit flavors,such as adipinic acid, succinic acid, fumaric acid, citric acid,tartaric acid, malic acid, acetic acid, lactic acid, phosphoric acid andglutaric acid or salts thereof. They are typically added in amounts of0.01 to 10%.

The chewing gum may also comprise the following surfactants and/orsolubilizers, especially when active ingredients are present. Asexamples of types of surfactants to be used as solubilizers in a chewinggum composition according to the invention reference is made to H. P.Fiedler, Lexikon der Hilfstoffe fur Pharmacie, Kosmetik and AngrenzendeGebiete, page 63-64 (1981) and the lists of approved food emulsifiers ofthe individual countries. The solubilizers referred to herein are alsorecognized by the term “emulsifiers”.

Both anionic, cationic, amphoteric, and nonionic solubilizers can beused, but usually the solubilizer, i.e. emulsifier used is eitheranionic or nonionic as mainly such solubilizers are approved for use infood or medicines. In cases where the active agent is reactive it isusually an advantage to use a nonionic solubilizer as it is not veryreactive and therefore does not affect the stability of the active agentunfavorably.

Suitable solubilizers include lecithines, polyoxyethylene stearate,polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono anddiacetyl tartaric acid esters of mono and diglycerides of edible fattyacids, citric acid esters of mono and diglycerides of edible fattyacids, saccharose esters of fatty acids, polyglycerol esters of fattyacids, polyglycerol esters of interesterified castor oil acid (E476),sodium stearoyllatylate, sodium lauryl sulfate and sorbitan esters offatty acids, which solubilizers are all known for use as foodemulsifiers, and polyoxyethylated hydrogenated castor oil (for instancesuch sold under the trade name CREMOPHOR), block copolymers of ethyleneoxide and propylene oxide (for instance as sold under the trade namePLURONIC or the trade name POLOXAMER), polyoxyethylene fatty alcoholethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters offatty acids and polyoxyethylene steraric acid ester, all known in theEEC for use as pharmaceutical-cosmetical emulsifiers.

Further examples of applicable solubilizers are polyoxyethylenestearates, such as for instance polyoxyethylene (8) stearate andpolyoxyethylene (40) stearate, the olyoxyethylene sorbitan fatty acidesters sold under the trade name TWEEN, for instance TWEEN 20(monolaurate), TWEEN 80 (monooleate), TWEEN 40 (monopalmitate), TWEEN 60(monostearate) or TWEEN 65 (tristearate), mono and diacetyl tartaricacid esters of mono and diglycerides of edible fatty acids, citric acidesters of mono and diglycerides of edible fatty acids, sodiumstearoyllatylate, sodium laurylsulfate, polyoxyethylated hydrogenatedcastor oil, block copolymers of ethylene oxide and propyleneoxide andpolyoxyethylene fatty alcohol ether. The solubilizer may either be asingle compound or a combination of several compounds.

The expression “solubilizer” is used in the present text to describeboth possibilities, the solubilizer used must be suitable for use infood and/or medicine.

Preferred solubilizers according to the invention include Atmos 300 NL,Cremophor EL, Cremophor A6, Lecithin, Modified lecithin, Poloxamer 188,Poloxamer 124, Poloxamer 237, Poloxamer 338, Polyoxyl 10 oleyl ether,Polyoxyl 20 cetostearyl ether, Polyethylene glycol, Polysorbate 20,Polysorbate 80, Polyoxyl 40 stearate, Polyoxyl 50 stearate, RS-5540,Sodium lauryl sulphate, Sorbitan monolaurate, Panodan 165, Lactodan B30,Dimodan PV, Artodan SP55, and Triodan R90. The most preferredsolubilizers according to the invention include cyclodextrins, CremophorRH40, Poloxamer 407, Polysorbate 60, Glyceryl monooleate, Glycerylmonostearate, Sorbitan monooleate, Sorbitan monopalmitate, Sorbitanmonostearate, Sorbitan sesquioleate, and Sorbitan trioleate.

According to the invention, a chewing gum is provided which releasestobacco alkaloid such as nicotine quickly when chewed by a user of thechewing gum. In order to obtain the effect of the considerably largeamount of nicotine released at once, it is important that conditions forabsorbing a large amount of the nicotine are provided as well.Otherwise, an undesirable large part of the fast releasing nicotine maybe wasted, e.g. by being swallowed by the user. According to theinvention, the increase in absorption of nicotine into the capillaryblood and bloodstream of the user may be obtained by way of addingcomponents for adjusting pH. Such components may be referred to asbuffering agents and may be applied for raising the pH above the normalhuman mouth pH in the saliva of the user. Hereby, nicotine is to alarger extent converted from ionized nicotine to unionized nicotine,which is more readily crossing the buccal mucosa of the user. Thus, theabsorption of nicotine into the bloodstream directly from the buccalcavity is increased and the part of wasted nicotine is reduced.

Components for adjusting pH include ion exchange resins and furthercomponents such as buffer agents. Buffer agents may be applied in thechewing gum in an amount in the range of 0.1% to 10%, preferably 0.5% to5% by weight of the chewing gum. While chewing a chewing gum accordingto the invention, the pH in the saliva may hereby be raised to a valuewithin the range of 7.5 to 10, preferably in the range of 8 to 9.5. Itshould be noted that a too large pH, such as about 9.5 to 10, mightcause a relatively unpleasant soap-like experience by the user of thechewing gum. According to the invention, it is important to keep the pHat an elevated level during the first 1 to 15 minutes, especially thefirst 1 to 10 minutes, as nicotine is quickly released during thisperiod of chewing. According to a preferred embodiment of the invention,more than half of the nicotine-content of the chewing gum may bereleased from the chewing gum within the first 5 minutes.

Examples of components for adjusting the pH in the oral cavity includefor instance: acceptable acids, such as adipinic acid, succinic acid,fumaric acid, or salts thereof or salts of citric acid, tartaric acid,malic acid, acetic acid, lactic acid, phosphoric acid and glutaric acidand acceptable bases, such as carbonates, hydrogen carbonates,phosphates, sulphates or oxides of sodium, potassium, ammonium,magnesium or calcium, especially magnesium and calcium.

According to the invention, preferred buffers for adjusting pH includesodium-carbonate, sodium hydrogen carbonate, potassium carbonate,potassium hydrogen carbonate, disodium hydrogen phosphate, dipotassiumhydrogen phosphate, dipotassium phosphate, trisodium phosphate,tripotassium phosphate, calcium hydroxide, magnesium oxide, potassiumcitrate, sodium glycinate, and combinations thereof. The most preferredbuffer agents according to the invention are alkali metal carbonates andphospates.

Fillers suitable for use in the chewing gum include magnesium andcalcium carbonate, ground limestone and silicate types such as magnesiumand aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide,talc, as well as titanium oxide, mono-, di- and tricalcium phosphate,sodium sulphate, cellulose polymers such as ethyl, methyl and wood ormixtures thereof.

Talc filler may be used in the chewing gum of the present invention thatmay come in contact with or employ acid flavors or provide an acidicenvironment needed to prevent degradation of an artificial sweetener byreacting with calcium carbonate type fillers. Mean particle size forcalcium carbonate and talc fillers typically range from about 0.1 micronto about 15 microns.

The fillers may also include natural organic fibers such as fruitvegetable fibers, grain, rice, cellulose and combinations thereof.

Antioxidants prolong shelf life and storage of gum base, finished gum ortheir respective components including fats and flavor oils.

Antioxidants suitable for use in gum base include butylatedhydroxyanisole (BHA), butylated hydroxytoluene (BHT), betacarotenes,tocopherols, acidulants such as Vitamin C, propyl gallate, othersynthetic and natural types or mixtures thereof.

Colorants and whiteners may include FD & C-type dyes and lakes, fruitand vegetable extracts, titanium dioxide, and combinations thereof.

The taste-masking agent improves the organoleptic properties of theproduct.

The masking agents include sucralose, zinc gluconate, ethyl maltol,glycine, acesulfame-K, aspartame, saccharin, fructose, xylitol, spraydried licorice root, glycerrhizine, dextrose, sodium gluconate, gluconodelta-lactone, ethyl vanillin, vanillin, normal and high-potencysweeteners, and a variety of appropriate flavors.

The chewing gum according to the present invention may also compriseactive agents other than nicotine. Active agents to be used inconnection with the present invention may be any substance desired to bereleased from the chewing gum. If an accelerated rate of release isdesired, corresponding to the effect obtained for the flavor, theprimary substances are those with limited water solubility, typicallybelow 10 g/100 ml including substances, which are entirely waterinsoluble. Examples are medicines, dietary supplements, oralcompositions, anti-smoking agents, highly potent sweeteners, pHadjusting agents, etc.

Further examples of active ingredients include paracetamol, benzocaine,cinnarizine, menthol, carvone, caffeine, chlorhexidine-di-acetate,cyclizine hydrochloride, 1,8-cineol, nandrolone, miconazole, mystatine,aspartame, sodium fluoride, nicotine, saccharin, cetylpyridiniumchloride, other quaternary ammonium compounds, vitamin E, vitamin A,vitamin D, glibenclamide or derivatives thereof, progesterone,acetylsalicylic acid, dimenhydrinate, cyclizine, metronidazole, sodiumhydrogencarbonate, the active components from ginkgo, the activecomponents from propolis, the active components from ginseng, methadone,oil of peppermint, salicylamide, hydrocortisone or astemizole.

Examples of active agents in the form of dietary supplements are forinstance salts and compounds having the nutritive effect of vitamin B2(riboflavin), B12, folinic acid, niacine, biotine, poorly solubleglycerophosphates, amino acids, the vitamins A, D, E and K, minerals inthe form of salts, complexes and compounds containing calcium,phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium,selenium, molybdenum, potassium, sodium or cobalt.

Furthermore, reference is made to lists of nutritients accepted by theauthorities in different countries such as for instance US code ofFederal Regulations, Title 21, Section 182.5013.1825997 and182.8013-182.8997.

Examples of active agents in the form of compounds for the care ortreatment of the oral cavity and the teeth are for instance boundhydrogen peroxide and compounds capable of releasing urea duringchewing.

Examples of active agents in the form of antiseptics are for instancesalts and compounds of guanidine and biguanidine (for instancechlorhexidine diacetate) and the following types of substances withlimited water-solubility: quaternary ammonium compounds (for instanceceramine, chloroxylenol, crystal violet, chloramine), aldehydes (forinstance paraformaldehyde), compounds of dequaline, polynoxyline,phenols (for instance thymol, para chlorophenol, cresol)hexachlorophene, salicylic anilide compounds, triclosan, halogenes(iodine, iodophores, chloroamine, dichlorocyanuric acid salts), alcools(3,4 dichlorobenzyl alcohol, benzyl alcohol, phenoxyethanol,phenylethanol), cf. furthermore Martindale, The Extra Pharmacopoeia,28th edition, pages 547-578; metal salts, complexes and compounds withlimited water-solubility, such as aluminum salts, (for instance aluminumpotassium sulfate AIK (S04) 2, 12H20) and furthermore salts, complexesand compounds of boron, barium, strontium, iron, calcium, zinc, (zincacetate, zinc chloride, zinc gluconate), copper (copper chloride, coppersulfate), lead, silver, magnesium, sodium, potassium, lithium,molybdenum, vanadium should be included; other compositions for the careof mouth and teeth: for instance; salts, complexes and compoundscontaining fluorine (such as sodium fluoride, sodiummonofluorophosphate,aminofluorides, stannous fluoride), phosphates, carbonates and selenium.

Cf. furthermore J. Dent. Res. Vol. 28 No. 2, pages 160-171, 1949,wherein a wide range of tested compounds are mentioned.

Examples of active agents in the form of agents adjusting the pH in theoral cavity include for instance: acceptable acids, such as adipinicacid, succinic acid, fumaric acid, or salts thereof or salts of citricacid, tartaric acid, malic acid, acetic acid, lactic acid, phosphoricacid and glutaric acid and acceptable bases, such as carbonates,hydrogen carbonates, phosphates, sulfates or oxides of sodium,potassium, ammonium, magnesium or calcium, especially magnesium andcalcium.

Examples of active agents in the form of anti-smoking agents include forinstance: nicotine, tobacco powder or silver salts, for instance silveracetate, silver carbonate and silver nitrate.

Examples of active agents in the form of medicines include caffeine,salicylic acid, salicyl amide and related substances (acetylsalicylicacid, choline salicylate, magnesium salicylate, sodium salicylate),paracetamol, salts of pentazocine (pentazocine hydrochloride andpentazocinelactate), buprenorphine hydrochloride, codeine hydrochlorideand codeine phosphate, morphine and morphine salts (hydrochloride,sulfate, tartrate), methadone hydrochloride, ketobemidone and salts ofketobemidone (hydrochloride), beta-blockers, (propranolol), calciumantagonists, verapamil hydrochloride, nifedinpine as well as suitablesubstances and salts thereof mentioned in Pharm. Int., November 1985,pages 267-271, Barney H. Hunter and Robert L. Talbert, nitroglycerine,erythrityl tetranitrate, strychnine and salts thereof, lidocaine,tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin,enzymes (for instance papain, trypsin, amyloglucosidase, glucoseoxidase,streptokinase, streptodomase, dextranase, alpha amylase), polypeptides(oxytocin, gonadorelin, (LH. RH), desmopressin acetate (DDAVP),isoxsuprine hydrochloride, ergotamine compounds, chloroquine (phosphate,sulfate), isosorbide, demoxytocin, heparin.

Other active ingredients include beta-lupeol, Letigen, Sildenafilcitrate and derivatives thereof.

Dental products include Carbamide, CPP Caseine Phospho Peptide;Chlorhexidine, Chlorhexidine di-acetate, Chlorhexidine Chloride,Chlorhexidine digluconate, Hexetedine, Strontium chloride, PotassiumChloride, Sodium bicarbonate, Sodium carbonate, Fluor containingingredients, Fluorides, Sodium fluoride, Aluminum fluoride, Ammoniumfluoride, Calcium fluoride, Stannous fluoride, Other fluor containingingredients Ammonium fluorosilicate, Potasium fluorosilicate, Sodiumfluorosilicate, Ammonium monofluorphosphate, Calcium monofluorphosphate,Potassium monofluorphosphate, Sodium monofluorphosphate, OctadecentylAmmonium fluoride, Stearyl Trihydroxyethyl PropylenediamineDihydrofluoride, Vitamins include A, B1, B2, B6, B12, Folin acid,niacin, Pantothensyre, biotine, C, D, E, K.

Minerals include Calcium, phosphor, magnesium, iron, Zink, Cupper, Iod,Mangan, Crom, Selene, Molybden. Other active ingredients include: Q10@,enzymes. Natural drugs including Ginkgo Biloba, ginger, and fish oil.The invention also relates to use of migraine drugs such as Serotoninantagonists: Sumatriptan, Zolmitriptan, Naratriptan, Rizatriptan,Eletriptan; nausea drugs such as Cyclizin, Cinnarizin, Dimenhydramin,Difenhydrinat; hay fever drugs such as Cetrizin, Loratidin, pain reliefdrugs such as Buprenorfin, Tramadol, oral disease drugs such asMiconazol, Amphotericin B, Triamcinolonaceton; and the drugs Cisaprid,Domperidon, Metoclopramid.

In general, chewing gum may be manufactured by sequentially adding thevarious chewing gum ingredients to a commercially available mixer knownin the art. After the initial ingredients have been thoroughly mixed,the gum mass is discharged from the mixer and shaped into the desiredform such as by rolling into sheets and cutting into sticks, extrudedinto chunks or casting into pellets.

Generally, the ingredients may be mixed by first melting the gum baseand adding it to the running mixer. Colors, active agents and/oremulsifiers may also be added at this time. A softener such as glycerinmay also be added at this time, along with syrup and a portion of thebulking agent/sweetener. Further portions of the bulking agent/sweetenermay then be added to the mixer. A flavoring agent is typically addedwith the final portion of the bulking agent/sweetener. A high-intensitysweetener is preferably added after the final portion of bulking agentand flavor has been added.

The entire mixing procedure typically takes from five to fifteenminutes, but longer mixing times may sometimes be required. Thoseskilled in the art will recognize that many variations of theabove-described procedure may be followed. Including the one-step methoddescribed in US patent application 2004/0115305 hereby incorporated asreference.

According to the invention, the form and shape of the tobacco alkaloidchewing gum may be any suitable and user-friendly structure.Accordingly, the gum center or gum may be e.g. in a form selected from apellet, a cushion-shaped pellet, a stick, a tablet, a chunk, a pastille,a pill, a ball and a sphere. Chewing gums are formed by extrusion,compression, rolling and may be center filled with liquids and/or solidsin any form.

In accordance with the invention, the chewing gum element may compriseabout 0.1 to about 75% by weight of an outer coating applied onto thechewing gum center. Thus, suitable coating types include hard coatings,film coatings and soft coatings of any composition including thosecurrently used in coating of chewing gum, pharmaceutical products andconfectioneries and any combination thereof.

One presently preferred outer coating type is a hard coating, which termis used in the conventional meaning of that term including sugarcoatings and sugar-free (or sugarless) coatings and combinationsthereof. The object of hard coating is to obtain a sweet, crunchy layer,which is appreciated by the user and it may moreover protect the gumcenters for various reasons. In a typical process of providing thechewing gum centers with a protective sugar coating, the gum centers aresuccessively treated in suitable coating equipment with aqueoussolutions of crystallisable sugar such as sucrose or dextrose, which,depending on the stage of coating reached, may contain other functionalingredients, e.g. fillers, binding agents, colors, etc. In the presentcontext, the sugar coating may contain further functional or activecompounds including flavor compounds and/or pharmaceutically activecompounds.

In the production of chewing gum it may, however, be preferred toreplace the cardiogenic sugar compounds in the coating by other,preferably crystallisable, sweetening compounds that do not have acariogenic effect. In the art such coating are generally referred to assugarless or sugar-free coatings. Presently preferred non-cariogenichard coating substances include polyols, e.g. sorbitol, maltitol,mannitol, xylitol, erythritol, lactitol, isomalt and tagatose which areobtained by industrial methods by hydrogenation of D-glucose, maltose,fructose or levulose, xylose, erythrose, lactose, isomaltulose andD-galactose, respectively and trehalose, which is a non-cariogenemono-di-saccharide.

In a typical hard coating process, as it will be described in details inthe following, a suspension containing crystallisable sugar and/orpolyol is applied onto the gum centers and the water it contains isevaporated off by blowing with air. This cycle must be repeated severaltimes, typically 3 to 80 times, in order to reach the swelling required.The term “swelling” refers to the increase in weight or thickness of theproducts, as considered at the end of the coating operation bycomparison with the beginning, and in relation to the final weight orthickness of the coated products. In accordance with the presentinvention, the coating layer constitutes about 0.1 to about 75% byweight of the finished chewing gum element, such as about 10 to about60% by weight, including about 15 to about 50% by weight.

In further useful embodiments, the outer coating of the chewing gumelement of the invention is an element that is subjected to a filmcoating process and which therefore comprises one or more film-formingpolymeric agents and optionally one or more auxiliary compounds, e.g.plasticizers, pigments and opacifiers. A film coating is a thinpolymer-based coating applied to a chewing gum center of any of theabove forms. The thickness of such a coating is usually between 20 and100 μm. Generally, the film coating is obtained by passing the chewinggum centers through a spray zone with atomized droplets of the coatingmaterials in a suitable aqueous or organic solvent vehicle, after whichthe material adhering to the gum centers is dried before the nextportion of coating is received. This cycle is repeated until the coatingis complete.

In the present context, suitable film-coating polymers include ediblecellulose derivatives such as cellulose ethers including methylcellulose(MC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC) andhydroxypropyl methylcellulose (HPMC). Other useful film-coating agentsare acrylic polymers and copolymers, e.g. methylacrylate aminoestercopolymer or mixtures of cellulose derivatives and acrylic polymers. Aparticular group of film-coating polymers, also referred to asfunctional polymers are polymers that, in addition to its film-formingcharacteristics, confer a modified release performance with respect toactive components of the chewing gum formulation. Such release modifyingpolymers include methylacrylate ester copolymers, ethylcellulose (EC)and enteric polymers designed to resist the acidic stomach environment,yet dissolve readily in the duodenum. The latter group of polymersincludes: cellulose acetate phtalate (CAP), polyvinyl acetate phtalate(PVAP), shellac, metacrylic acid copolymers, cellulose acetatetrimellitate (CAT) and HPMC. It will be appreciated that the outer filmcoating according to the present invention may comprise any combinationof the above film-coating polymers.

In other embodiments, the film-coating layer of the chewing gum elementsaccording to the invention comprises a plasticizing agent having thecapacity to alter the physical properties of a polymer to render it moreuseful in performing its function as a film-forming material. Ingeneral, the effect of plasticizers will be to make the polymer softerand more pliable as the plasticizer molecules interpose themselvesbetween the individual polymer strands thus breaking downpolymer-polymer interactions. Most plasticizers used in film coating areeither amorphous or have very little crystallinity. In the presentcontext, suitable plasticizers include polyols such as glycerol,propylene glycol, polyethylene glycol, e.g. the 200-6000 grades hereof,organic esters such as phtalate esters, dibutyl sebacate, citrate estersand thiacetin, oils/glycerides including castor oil, acetylatedmonoglycerides and fractionated coconut oil.

The choice of film-forming polymer(s) and plasticizing agent(s) for theouter coating of the present chewing gum element is made with dueconsideration for achieving the best possible barrier properties of thecoating in respect of dissolution and diffusion across the film ofmoisture and gasses.

The film coating of the chewing gum elements may also contain one ormore colorants or opacifiers. In addition to providing a desired colorhue, such agents may reflect light or form a barrier against moistureand gasses. Suitable color-ants/pacifiers include organic dyes and theirlakes, inorganic coloring agents, e.g. titanium oxide and natural colorssuch as e.g. β-carotene or chlorophyll.

Additionally, film coatings may contain one or several auxiliarysubstances such as flavors and waxes or saccharide compounds such aspolydextrose, dextrins including maltodextrin, lactose, modified starch,a protein such as gelatine or zein, a vegetable gum and any combinationthereof.

In one specific embodiment the chewing gum center is in the form of astick which is provided on at least one side with an edible filmcomprising layer of a coating of a film forming agent, e.g. a cellulosederivative, a modified starch, shellac, gum arabic, a dextrin, gelatine,zein, a vegetable gum, a synthetic polymer and any combination thereof,and a wax such as beeswax, carnauba wax, microcrystalline wax, paraffinwax and combinations thereof.

The following examples are given for illustration, but not limitation ofthe invention.

Example 1 Preparation of Gum Base

A gum base is prepared, which comprises the following ingredients.

Ingredients Percent by weight Elastomer 10 Natural resin 28 Syntheticresin 22 Fat/wax/exmulsifiers 23 Fillers 17

It should be emphasized that several other gum base compositions may beapplied within the scope of the invention.

The elastomer and filler are added to a mixing kettle provided withmixing means like e.g. horizontally placed Z-shaped arms. The kettle hasbeen preheated for 15 minutes to a temperature of about 120° C. Therubber is broken into small pieces and softened with mechanical actionin the kettle.

The resin is slowly added to the elastomer until the mixture becomeshomogeneous. The remaining resin is then added to the kettle and mixedfor 10-20 minutes. The softening ingredients are added and mixed for20-40 minutes until the whole mixture becomes homogeneous.

The mixture is then discharged into the pan and allowed to cool to roomtemperature from the discharged temperature of 120° C.

Example 2 Preparation of Nicotine-Containing Chewing Gum

Chewing gum is prepared by use of the gum base in example 1 andaccording to a conventional mechanical mixing procedure during moderateuse of heating as described below.

Gum base 57.4% Filler 14.6% Nicotine Polacrilex Nicotine 0.2% Ionexchange resin 0.8% Buffer agents Sodiumhydrogencarbonate 1.0% Sodiumcarbonate 2.0% Sorbitol powder 14.4% Liquid sweetener 1.5% Intensesweetener 0.4% Flavor 7.7%

Gum base and filler are mixed in a mixing kettle provided with mixingmeans like e.g. horizontally placed Z-shaped arms. The kettle has beenpreheated to a temperature of up to approximately 50° C.

When the content is homogenous the other ingredient is added accordingto a specified time schedule. Nicotine is added in the first half of themixing process and can be added as pure nicotine, as a nicotine salt orbound to an ion exchange resin, e.g. Amberlite IRP 64.

The pieces may be formulated with 0.1-8 mg of nicotine per piecepreferably 2 or 4 mg. The pieces evaluated below comprise 2 mg nicotinecomplex.

Example 3

Chewing gum is prepared by use of the gum base in example 1 andaccording to a conventional mechanical mixing procedure during moderateuse of heating according to the procedure explained and described inconnection with example 2.

Gum base 43.9% Filler 11.1% Nicotine Polacrilex Nicotine 0.2% Ionexchange resin 0.8% Buffer agents Sodiumhydrogencarbonate 1.0% Sodiumcarbonate 2.0% Sorbitol powder 31.4% Liquid sweetener 1.5% Intensesweetener 0.4% Flavor 7.7%

Ex Example 4

Chewing gum is prepared by use of the gum base in example 1 andaccording to a conventional mechanical mixing procedure during moderateuse of heating according to the procedure explained and described inconnection with example 2.

Gum base 31.9% Filler 8.1% Nicotine Polacrilex Nicotine 0.2% Ionexchange resin 0.8% Buffer agents Sodiumhydrogencarbonate 1.0% Sodiumcarbonate 2.0% Sorbitol powder 46.4% Liquid sweetener 1.5% Intensesweetener 0.4% Flavor 7.7%

Example 5

Chewing gum is prepared by use of the gum base in example 1 andaccording to a conventional mechanical mixing procedure during moderateuse of heating according to the procedure explained and described inconnection with example 2.

Gum base 23.9% Filler 6.1% Nicotine Polacrilex Nicotine 0.2% Ionexchange resin 0.8% Buffer agents Sodiumhydrogencarbonate 1.0% Sodiumcarbonate 2.0% Sorbitol powder 56.4% Liquid sweetener 1.5% Intensesweetener 0.4% Flavor 7.7%

Examples 6-9

The chewing gums of examples 2-5 were coated by means of hard coating.Coating was applied.

Coating may e.g. be applied according to the methods disclosed in U.S.Pat. No. 6,627,234, hereby included by reference.

Example 10 Evaluation of Release and Taste Masking of Chewing Gum ofExamples 2-5

The below table 1 illustrates nicotine release of the chewing gums ofexamples 2-5.

TABLE 1 Nicotine release in percentage of the full amount of nicotinecontained in the chewing gum. Chewing % in chewing gum gum of accordingelastomer- % RELEASE at minutes to example and resin 5 min 10 min 20 min30 min Ex. 2 34.4 23 50 73 86 Ex. 3 26.3 32 59 78 88 Ex. 4 19.1 59 77 8794 Ex. 5 14.3 64 80 89 94

FIG. 1 furthermore illustrates the results, and as it appears clearlyfrom the FIGURE, a substantial increased release is unexpectedlyappearing as a result of altering the percentage of elastomer- and resincompounds from 26.3% to 19.1%. In other words, a surprisingly increasedrelease effect is obtained when lowering the content of elastomer- andresin compounds in the area of about 20 to 25% by weight of the chewinggum.

The below table 2 illustrates nicotine release of the chewing gums ofexamples 2-5, where the release percentages obtained by chewing gums ofexample 2 is given the index 100, and the release percentages obtainedby chewing gums of examples 3-5 are related to example 2 and given anindex based thereon.

TABLE 2 Nicotine release percentage indexed according to example 2.Chewing % in chewing gum gum of according elastomer- Index of RELEASE atminutes to example and resin 5 min 10 min 20 min 30 min Ex. 2 34.4 100100 100 100 Ex. 3 26.3 139 118 107 102 Ex. 4 19.1 257 154 119 109 Ex. 514.3 278 160 122 109

The perceptual release is evaluated with respect to taste of thereleased nicotine, and the results are presented in table 3. A scale isapplied where reference is made to normal release by a conventional highgum base nicotine chewing gum of example 2.

The reference evaluation of a nicotine taste masking is referred to asA=good, B=acceptable, C=non-acceptable. The perceptual releases ofnicotine at different times are mapped into the evaluation as being“good” and the examples 3-5 are evaluated relative to example 2.

TABLE 3 Sensory evaluation of the nicotine releasing chewing gums ofexample 2 to 5. Chewing % in chewing gum gum of according elastomer-Evaluation of taste masking at minutes to example and resin 5 min 10 min20 min 30 min Ex. 2 34.4 A A A A Ex. 3 26.3 B A A A Ex. 4 19.1 C B A AEx. 5 14.3 C B A A

It may be appreciated from table 3 that the initial increased level ofreleased nicotine has a significant effect on the sensory evaluation.

Example 11 Evaluation of Taste Masking of Chewing Gum of Examples 6-9

The perceptual release is evaluated with respect to taste of thereleased nicotine, and the results are presented in table 4. A scale isapplied where reference is made to normal release by a conventional highgum base nicotine chewing gum of example 2.

The reference evaluation of a nicotine taste masking is referred to asA=good, B=acceptable, C=non-acceptable. The perceptual releases ofnicotine at different times are mapped into the evaluation as being“good” and the examples 7-9 are evaluated relative to example 2.

TABLE 4 Sensory evaluation of the nicotine releasing chewing gums ofexample 6 to 9. Chewing % in chewing gum gum of according elastomer-Evaluation of taste masking at minutes to example and resin 5 min 10 min20 min 30 min Ex. 6 34.4 A A A A Ex. 7 26.3 A A A A Ex. 8 19.1 B B A AEx. 9 14.3 B B A A

As it may be read from table 4, it has been found that a coating layerhas a taste masking effect, and the effect is seen in the presentexamples 8 and 9 within the first five minutes of chewing.

What is claimed is:
 1. Tobacco alkaloid releasing chewing gum comprisingtobacco alkaloid, gum base, and chewing gum ingredients, said gum basecomprising elastomer- and resin-compounds in an amount in the range ofabout 2 to 26.3% by weight of said chewing gum, wherein at least 32% ofthe tobacco alkaloid comprised in said chewing gum prior to chewing willbe released within five minutes following initiation of chewing andwherein at least 59% of the tobacco alkaloid comprised in said chewinggum prior to chewing will be released within ten minutes followinginitiation of chewing.
 2. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said chewing gum comprises tobaccoalkaloid in an amount of 0.1 mg to 10 mg.
 3. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said chewing gum comprisestobacco alkaloid in an amount of 0.1 mg to 10 mg in the gum base of thechewing gum.
 4. Tobacco alkaloid releasing chewing gum according toclaim 1, wherein said tobacco alkaloid is in a form selected fromtobacco alkaloid salts, tobacco alkaloid bound in a complex, or anycombination thereof.
 5. Tobacco alkaloid releasing chewing gum accordingto claim 1, wherein said tobacco alkaloid is nicotine.
 6. Tobaccoalkaloid releasing chewing gum according to claim 5, wherein saidnicotine is in a form selected from nicotine salts, nicotine free base,nicotine bound in a complex, or any combination thereof.
 7. Tobaccoalkaloid releasing chewing gum according to claim 4, wherein saidcomplex comprises an ion exchange resin.
 8. Tobacco alkaloid releasingchewing gum according to claim 7, wherein said ion exchange resin is aweakly acidic cation exchange resin.
 9. Tobacco alkaloid releasingchewing gum according to claim 4, wherein said complex comprises anadsorbent.
 10. Tobacco alkaloid releasing chewing gum according to claim9, wherein said adsorbent is selected from the group consisting offinely divided silicic acid, amorphous silica, magnesium silicate,calcium silicate, kaolin, clays, crystalline aluminosilicates, macaloidbentonite, activated carbon, alumina, hydroxylapatite, microcrystallinecellulose, and any combination thereof.
 11. Tobacco alkaloid releasingchewing gum according to claim 6, wherein said nicotine salts areselected from the group consisting of nicotine hydrochloride, nicotinedihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotinesulfate, nicotine zinc chloride, nicotine salicylate, and anycombination thereof.
 12. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said chewing gum comprises emulsifiers inan amount in the range of 0.1% to 25% by weight of said chewing gum. 13.Tobacco alkaloid releasing chewing gum according to claim 12, wherein atleast 50% of said emulsifiers are comprised in said gum base. 14.Tobacco alkaloid releasing chewing gum according to claim 12, whereinsaid emulsifiers are selected from the group consisting ofcyclodextrins, polyoxyethylene castor oil derivatives, polyoxyethylenealkyl ethers, macrogol alkyl ethers, block copolymers of ethylene andpropylene oxides, polyoxyethylene alkyl ethers, polyoxyethylene glycols,polyoxyethylene sorbitan fatty acid esters, polyoxyethylene (20)sorbitan monostearates, polyoxyethylene (20) sorbitan monooleates,polyoxyethylene stearates, sobitan esters, diacetyl tartaric ester ofmonoglycerides, lactylated monoglycerides, and any combination thereof.15. Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid chewing gum comprises an emulsifier having an HLB value of 7 orless.
 16. Tobacco alkaloid releasing chewing gum according to claim 1,wherein said chewing gum comprises one or more emulsifiers having an HLBvalue of at least
 7. 17. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said chewing gum comprises one or moreemulsifiers having an HLB value of at least
 10. 18. Tobacco alkaloidreleasing chewing gum according to claim 1, wherein said chewing gumcomprises one or more emulsifiers of HLB value below about 7 and one ormore emulsifiers of HLB value above about 7, said emulsifiers of HLBvalue below about 7 being applied in the gum base, and said emulsifiersof HLB value above about 7 being applied in the final chewing gumcomposition along with the chewing gum ingredients.
 19. Tobacco alkaloidreleasing chewing gum according to claim 1, wherein said resin-compoundscomprise natural resins constituting an amount in the range of 0.1 to20% by weight of said chewing gum.
 20. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said resin-compounds comprisenatural resins constituting an amount in the range of 1 to 15% by weightof said chewing gum.
 21. Tobacco alkaloid releasing chewing gumaccording to claim 19, wherein said natural resins comprise ester gums.22. Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid resin-compounds comprise synthetic resins constituting an amount inthe range of 0.1 to 20% by weight of said chewing gum.
 23. Tobaccoalkaloid releasing chewing gum according claim 1, wherein saidresin-compounds comprise synthetic resins constituting an amount in therange of 1 to 15% by weight of said chewing gum.
 24. Tobacco alkaloidreleasing chewing gum according to claim 1, wherein said resin compoundscomprise terpene resins derived from alpha-pinene, beta-pinene and/ord-limonene.
 25. Tobacco alkaloid releasing chewing gum according toclaim 22, wherein said synthetic resins comprise polyvinyl acetate(PVAc).
 26. Tobacco alkaloid releasing chewing gum according to claim 1,wherein said elastomer compounds comprise at least 1% by weight of saidchewing gum.
 27. Tobacco alkaloid releasing chewing gum according toclaim 1, wherein said elastomer compounds constitute less than 20% byweight of said chewing gum.
 28. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said elastomer compounds constitute anamount in the range of about 0.001 to 20% by weight of said chewing gum.29. Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid elastomer compounds are synthetic elastomers selected from thegroup consisting of butadiene-styrene copolymers, polyisobutadiene,isobutylene-isoprene copolymers, butyl rubber, polybutene,polybutadiene, polyisobutylene, polyvinyl acetate, polyethylene, vinylacetate/vinyl laurate copolymer, vinyl acetate/vinyl stearate copolymer,ethylene/vinyl acetate copolymer, polyvinyl alcohol, and any derivativesor mixtures thereof.
 30. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said elastomer compounds are naturalelastomers selected from the group consisting of natural rubber, latex,guayule, natural gums, jelutong, lechi caspi, perillo, sorva,massaranduba balata, massaranduba chocolate, nispero, rosidinha, chicle,gutta percha, gutta kataiu, niger gutta, tunu, chilte, chiquibul, guttahang kang, and any combination thereof.
 31. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said chewing gum comprises pHcontrolling components.
 32. Tobacco alkaloid releasing chewing gumaccording to claim 31, wherein said pH controlling components areselected from the group consisting of sodium carbonate, sodium hydrogencarbonate, potassium carbonate, potassium hydrogen carbonate,dipotassium phosphate, potassium citrate, and any combination thereof.33. Tobacco alkaloid releasing chewing gum according to claim 31,wherein said pH controlling components comprise an amount in the rangeof 0.1% to 5% by weight of said chewing gum.
 34. Tobacco alkaloidreleasing chewing gum according to claim 31, wherein said pH controllingcomponents provide a pH value in the range of 7.4 to 10 in the buccalcavity of a user of said chewing gum.
 35. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said chewing gum comprises acoating.
 36. Tobacco alkaloid releasing chewing gum according to claim35, wherein said coating is a hard coating.
 37. Tobacco alkaloidreleasing chewing gum according to claim 35, wherein said coating is asoft coating or a film coating.
 38. Tobacco alkaloid releasing chewinggum according to claim 35, wherein said coating comprises a furtheramount of tobacco alkaloid.
 39. Tobacco alkaloid releasing chewing gumaccording to claim 35, wherein said coating has a weight above 20 mg.40. Tobacco alkaloid releasing chewing gum according to claim 35,wherein said coating makes up more than 2% by weight of the chewing gum.41. Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid chewing gum comprises a coating comprising a portion of at least100 milligrams and wherein said portion comprises high-intensitysweetener.
 42. Tobacco alkaloid releasing chewing gum according to claim41, wherein said coating comprising a portion of at least 100 milligramsand wherein said portion comprises bulk sweetener.
 43. Tobacco alkaloidreleasing chewing gum according to claim 41, wherein said coatingcomprising at least a portion of at least 100 milligrams and whereinsaid portion comprises flavor.
 44. Tobacco alkaloid releasing chewinggum according to claim 1, wherein said chewing gum comprises sweeteners.45. Tobacco alkaloid releasing chewing gum according to claim 44,wherein said sweeteners comprises bulk sweeteners, sugar sweeteners,sugar substitute sweeteners, artificial sweeteners, high-intensitysweeteners, or any combination thereof.
 46. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said chewing gum comprises oneor more flavoring agents.
 47. Tobacco alkaloid releasing chewing gumaccording to claim 46, wherein said flavoring agents comprises naturaland synthetic flavorings.
 48. Tobacco alkaloid releasing chewing gumaccording to claim 46, wherein said flavoring agents comprise essentialoils, essences, extracts, powders, acids, coconut, coffee, chocolate,vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma,honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple,strawberry, raspberry, apple, pear, peach, apricot, blackberry, cherry,pineapple, plum essence, clove oil, bay oil, anise, thyme, cedar leafoil, nutmeg, cinnamon, peppermint, wintergreen, spearmint, eucalyptus,mint, or any combination thereof.
 49. Tobacco alkaloid releasing chewinggum according to claim 1, wherein said chewing gum comprises filler. 50.Tobacco alkaloid releasing chewing gum according to claim 49, whereinsaid filler is comprised within said gum base.
 51. Tobacco alkaloidreleasing chewing gum according to claim 49, wherein said filler isincorporated in said chewing gum along with said chewing gumingredients.
 52. Tobacco alkaloid releasing chewing gum according toclaim 1, wherein said chewing gum has a weight in the range of 0.1 to 10grams.
 53. Tobacco alkaloid releasing chewing gum according to claim 1,wherein said chewing gum is multimodular.
 54. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said chewing gum comprises atobacco alkaloid releasing module, which is a substantially gum basefree module.
 55. Tobacco alkaloid releasing chewing gum according toclaim 1, wherein said chewing gum is a chewing gum tablet.
 56. Tobaccoalkaloid releasing chewing gum according to claim 1, wherein saidchewing gum comprises further active ingredients.
 57. Tobacco alkaloidreleasing chewing gum according to claim 56, wherein an amount of saidfurther active ingredients is within the range of about 0.01 mg to 1000mg.
 58. Tobacco alkaloid releasing chewing gum according to claim 56,wherein said further active ingredients are selected from the groupconsisting of dental agents and agents for treating pain, headache, orweight-gain.
 59. Tobacco alkaloid releasing chewing gum according toclaim 56, wherein said further active ingredients are selected from thegroup consisting of cetirizine, loratadine, phenylephrine, paracetamol,cimetidine, ranitidine, ibuprofen, calcium carbonate, vitamin D3,sumatriptan, ketoprofen, naproxen, morphine, famotidine,chlorpheniramine, dextromethorphan, metformin, and any combinationthereof.
 60. Tobacco alkaloid releasing chewing gum according to claim12, wherein said emulsifiers are selected from the group consisting ofcyclodextrins, polyoxyethylene (20) sorbitan monostearates, sorbitanfatty acid esters, glycerol polyethyleneglycol oxystearate, glycerolmonostearate, glycerol monooleate, block copolymers of ethylene andpropylene oxides, and mixtures thereof.
 61. Tobacco alkaloid releasingchewing gum according to claim 1, wherein said tobacco alkaloid iscomprised in tobacco powder.
 62. Tobacco alkaloid releasing chewing gumaccording to claim 1, wherein said chewing gum is prepared bycompression of said chewing gum.
 63. Tobacco alkaloid releasing chewinggum according to claim 1, wherein said gum base comprises elastomer- andresin-compounds in an amount in the range of about 2 to 19.1% by weightof said chewing gum, wherein at least 59% of the tobacco alkaloidcomprised in said chewing gum prior to chewing will be released withinfive minutes following initiation of chewing and wherein at least 77% ofthe tobacco alkaloid comprised in said chewing gum prior to chewing willbe released within ten minutes following initiation of chewing. 64.Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid gum base comprises elastomer- and resin-compounds in an amount inthe range of about 2 to 19.1% by weight of said chewing gum, wherein atleast 77% of the tobacco alkaloid comprised in said chewing gum prior tochewing will be released within ten minutes following initiation ofchewing and wherein at least 87% of the tobacco alkaloid comprised insaid chewing gum prior to chewing will be released within twenty minutesfollowing initiation of chewing.
 65. Tobacco alkaloid releasing chewinggum according to claim 1, wherein said gum base comprises elastomer- andresin-compounds in an amount in the range of about 2 to 19.1% by weightof said chewing gum, wherein at least 87% of the tobacco alkaloidcomprised in said chewing gum prior to chewing will be released withintwenty minutes following initiation of chewing and wherein at least 94%of the tobacco alkaloid comprised in said chewing gum prior to chewingwill be released within thirty minutes following initiation of chewing.66. Tobacco alkaloid releasing chewing gum according to claim 1, whereinsaid gum base comprises elastomer- and resin-compounds in an amount inthe range of about 2 to 19.1% by weight of said chewing gum, wherein atleast 59% of the tobacco alkaloid comprised in said chewing gum prior tochewing will be released within five minutes following initiation ofchewing and wherein at least 87% of the tobacco alkaloid comprised insaid chewing gum prior to chewing will be released within twenty minutesfollowing initiation of chewing.
 67. Tobacco alkaloid releasing chewinggum comprising tobacco alkaloid, gum base, and chewing gum ingredients,said gum base comprising elastomer- and resin-compounds in an amount inthe range of about 2 to 26.3% by weight of said chewing gum, wherein atleast 59% of the tobacco alkaloid comprised in said chewing gum prior tochewing will be released within ten minutes following initiation ofchewing and wherein at least 78% of the tobacco alkaloid comprised insaid chewing gum prior to chewing will be released within twenty minutesfollowing initiation of chewing.
 68. Tobacco alkaloid releasing chewinggum comprising tobacco alkaloid, gum base, and chewing gum ingredients,said gum base comprising elastomer- and resin-compounds in an amount inthe range of about 2 to 26.3% by weight of said chewing gum, wherein atleast 78% of the tobacco alkaloid comprised in said chewing gum prior tochewing will be released within twenty minutes following initiation ofchewing and wherein at least 88% of the tobacco alkaloid comprised insaid chewing gum prior to chewing will be released within thirty minutesfollowing initiation of chewing.
 69. Tobacco alkaloid releasing chewinggum comprising tobacco alkaloid, gum base, and chewing gum ingredients,said gum base comprising elastomer- and resin-compounds in an amount inthe range of about 2 to 26.3% by weight of said chewing gum, wherein atleast 32% of the tobacco alkaloid comprised in said chewing gum prior tochewing will be released within five minutes following initiation ofchewing and wherein at least 78% of the tobacco alkaloid comprised insaid chewing gum prior to chewing will be released within twenty minutesfollowing initiation of chewing.